Teratogen Use in Women of Childbearing Potential: An Intervention Study

Karie A. Morrical-Kline; Alison M. Walton; Tracey M. Guildenbecher

doi:10.3122/jabfm.2011.03.100198

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Figure 1.
Patient inclusion and exclusion.
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Figure 2.
Patient characteristics affecting risk documentation.

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Table 1.

Food and Drug Administration (FDA) Pregnancy Category Definitions⁸

FDA Pregnancy Category	Definition
A	Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm seems to be remote.
B	Either animal reproductive studies have not demonstrated a fetal risk but there are no controlled studies of pregnant women, or animal reproductive studies have shown adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk during later trimesters).
C	Either studies in animals have revealed adverse effects on the fetus (teratogenic or embrocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
D	There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
X	Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

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Table 2.

Survey Administered to Physicians Before and After Educational Initiative

Survey Question	Survey Response	Correct response Before Intervention (n = 36) (n [%])	Correct response After Intervention (n = 38) (n [%])	P
1. Which pregnancy drug category are ACE-I and ARB in?	a. A	15 (41.7)	22 (57.9)	.176
	b. B
	c. C^*
	d. D^*
	e. X
	f. I don’t know
2. Which pregnancy drug category is statin in?	a. A	10 (27.8)	19 (50)	<.065
	b. B
	c. C
	d. D
	e. X^*
	f. I don’t know
3. ACE-I and ARB primarily affect which fetal system if exposed during the second and third trimester?	a. Lung	23 (63.9)	28 (73.7)	.440
	b. Cardiovascular
	c. Renal^*
	d. Nervous
	e. I am unsure
4. There is increasing evidence that ACE-I/ARB have adverse effects to fetuses exposed during the first trimester.	a. True^*	19 (52.8)	33 (86.8)	.650
	b. False
	c. I am not sure
5. Statin has been shown to adversely affect fetal development in human studies.	a. True	7 (19.4)	9 (23.7)	.652
	b. False^*
	c. I am not sure
6. In the past several months have you prescribed an ACE-I, ARB, or statin to any women between the ages of 15 to 45?	a. Yes^†	8 (22.2)	10 (26.3)	1.000
	b. No
	c. I’m not sure
7. When prescribing ACE-I, ARB, or statin, do you consider the possibility of the patients becoming pregnant while taking the drug?	a. Yes, always^†	24 (66.7)	31 (81.6)	.678
	b. Usually^†
	c. Sometimes
	d. No, never
8. If you do consider possible pregnancy when prescribing ACE-I/ARB and statin, do you make an effort to document use of contraception and discussion of possible risks?	a. Yes, always^†	25 (69.4)	28 (73.7)	.091
	b. Usually^†
	c. Sometimes
	d. No, never
	e. I don’t consider pregnancy risk when prescribing
Physician Demographics
9. Gender	a. Male	19 (52.85)	17 (44.7)	.316
9. Gender	b. Female	17 (47.2)	21 (55.3)
10. Current year of residency training	a. PGY-1	16 (44.4)	18 (47.4)	.889
	b. PGY-2	11 (30.6)	10 (26.3)
	c. PGY-3	8 (22.2)	9 (23.7)
	d. PGY-4	2 (5.6)	1 (2.6)
11. Current residency training program	a. FM	13 (36.1)	12 (31.6)	.770
	b. IM	5 (13.9)	8 (21.1)
	c. FM/IM	5 (13.9)	3 (7.9)
	d. OB/GYN	9 (25.0)	8 (21.1)
	e. Transitional	3 (8.3)	7 (18.4)

↵* Correct response to survey question.
↵† Considered preferred answers.
ACE-I, angiotensin-converting enzyme inhibitors; ARB, angiotensin receptor blockers; statin, HMG-CoA reductase inhibitors; PGY, postgraduate year; IM, internal medicine; FM, family medicine; OB/GYN, obstetrics/gynecology.

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Table 3.

Patient and Physician Demographics

Characteristics	Before Intervention (n = 200) (n [%])	After Intervention (n = 131) (n [%])	P
Patient
Age (years)			.728
15 to 40 years old	124 (62.0)	84 (64.1)
41 to 45 years old	76 (38.0)	47 (35.9)
Medication prescribed
ACE-I	129 (64.5)	95 (72.5)	.149
ARB	29 (14.5)	17 (13.0)	.747
Statin	88 (44.0)	50 (38.2)	.307
Disease state indication
HTN	154 (77.0)	109 (83.2)	.211
DM	88 (44.0)	62 (47.3)	.574
HLD	90 (45.0)	56 (42.7)	.735
Use of contraception^*	44 (22.0)	38 (29.0)	.154
Pregnancy test at prescription	5 (2.5)	4 (3.1)	.744
Physician
Resident training program			.176
IM	102 (51.0)	59 (45.0)
FM	54 (27.2)	37 (28.2)
IM/FM combined program	7 (3.5)	9 (6.9)
OB/GYN	5 (2.5)	0 (0)
Faculty	32 (16.0)	26 (19.8)
PGY of Training			<.001
PGY1	0 (0)	15 (11.5)
PGY2	38 (19)	39 (29.8)
PGY3	60 (30.0)	43 (32.8)
Graduate 2009	60 (30.0)	3 (2.3)
Faculty	35 (17.5)	31 (23.7)
Graduate	7 (3.5)	0 (0)

↵* Method of contraception not different between treatment groups.
ACE-I, angiotensin-converting enzyme inhibitors; ARB, angiotensin receptor blockers; statin, HMG-CoA reductase inhibitors; HTN, hypertension; DM, diabetes; HLD, hyperlipidemia; IM, Internal Medicine; FM, Family Medicine; OB/GYN, Obstetrics/Gynecology; PGY, postgraduate year.

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Table 4.

Primary Outcome Measures

	Before Intervention (n = 200) (n [%])	After Intervention (n = 131) (n [%])	P
Frequency of targeted medications prescribed
ACE-I	129 (64.5)	95 (72.5)	.149
ARB	29 (14.5)	17 (13.0)	.747
Statin	88 (44.0)	50 (38.2)	.307
Frequency of risk documentation	40 (20)	49 (37.4)	<.001